MalfunctionJDN
IMPLANT, FIXATION DEVICE, SPINAL
Received Mar 24, 2023 · Event occurred Feb 17, 2023
Report 3009051471-2023-00006 · MDR key 16616100
Device
Generic name
Implant, Fixation Device, Spinal
Manufacturer
Ctl Medical CorporationProduct problems
- Material Split, Cut or Torn
- Material Split, Cut or Torn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
REPORT OF PEDICLE SCREW NECK SHEARING IN A PEDICLE SCREW CONTRUCT WAS DELIVERED TO CTL ON 02/17/2023 BY THE DISTRIBUTOR REPRESENTATIVE. NO INJURY OR HARM TO THE PATIENT HAS BEEN REPORTED. NO INFORMATION REGARDING PATIENT/SURGEON/SYSTEM USAGE HAS BEEN PROVIDED. COMPANY ATTEMPTED TO REACH OUT TWICE WITHOUT SUCCESSFUL REPONSE. FAILURE MODALITY (SHEARING OF THE SCREW NECK) IS AN INDICATION THAT CONSTRUCT WAS UNDER BUILT TO WITHSTAND THE LOADING CONDITIONS, BUT THE CASE IS INCONCLUSIVE WITHOUT ADDITIONAL INCIDENT INFORMATION.